510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KOIClass II

Stimulator, Nerve, Peripheral, Electric

21 CFR 868.2775 / Anesthesiology
FDA source (opens on fda.gov)

KOI is the FDA product code for Stimulator, Nerve, Peripheral, Electric, a class II device type, regulated under 21 CFR 868.2775. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KOI
Device name
Stimulator, Nerve, Peripheral, Electric
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
29
Ingested recalls
1

Clearances, product code KOI

By decision year
29 clearances under product code KOI with a decision year between 1984 and 2026, 1996 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KOI by decision year
YearClearances
19841
19861
19932
19963
19972
19992
20011
20042
20051
20161
20182
20191
20201
20212
20223
20241
20252
20261

Applicants with the most clearances

Product code KOI
Applicants holding the most 510(k) clearances under product code KOI
ApplicantClearances
Nihon Kohden Corp.3
bioMerieux, Inc.3
Senzime AB3
Blink Device Company2
Idmed2
Life-Tech Intl., Inc.2
MIPM Mammendorfer Institut fur Physik und Medizin GmbH2
Biometer Intl. A/S1
Datex Division Instrumentarium Corp.1
Datex Medical Instrumentation, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 46 companies shown, in name order